KSD-101 in Patients With EBV-associated Hematological Malignancies

A Prospective, Single-arm, Observational Real-world Clinical Practice Study on the Efficacy and Safety of Dendritic Cell-based Vaccines (KSD-101) in Patients With EBV-associated Hematological Malignancies

Epstein-Barr virus (EBV) is a double-stranded DNA virus belonging to the Gammaherpesvirinae subfamily of Herpesviridae. It primarily infects B cells and pharyngeal epithelial cells, and can also infect NK cells and T cells. EBV is closely associated with a variety of hematological malignancies, including EBV-positive diffuse large B-cell lymphoma (EBV+DLBCL), NK/T-cell lymphoma (NKTCL), Hodgkin lymphoma (HL), Burkitt lymphoma (BL), EBV-positive nodal T-follicular helper cell lymphoma, angioimmunoblastic type (EBV+nTFHL-AI), and primary cutaneous T-cell lymphoma (CTCL). EBV-positive hematological malignancies are characterized by poor prognosis and limited therapeutic options, and there are currently no approved EBV-specific therapies. KSD-101 is a novel dendritic cell vaccine loaded with EBV-associated tumor-like composite antigens, which possesses strong antigen-presenting capacity and can initiate EBV-specific T-cell immunity. This study aims to investigate the real-world clinical efficacy and safety of KSD-101, providing an important reference for optimizing its clinical application, as well as theoretical support for the further development of novel therapeutic strategies.

Study Overview

• Status: Not yet recruiting
• Conditions: EBV Associated Lymphoid Neoplasms
• Intervention / Treatment: Biological: Autologous dendritic cell vaccine

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• China
  • Hainan
    • Qionghai, Hainan, China
      • Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)
      • Contact: Wei-Li Zhao; Phone Number: 0898-62629196; Email: zwl_trial@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Ruijin-Hainan Hospital，Shanghai Jiao Tong University School of Medicine (Hainan Boao Research Hospital)

Description

Inclusion Criteria:

• Patients with EBV-associated hematological malignancies who receive KSD-101 Vaccine Therapy (non-genetically modified) .

  1. Patients aged 12 years or older on the date of signing the informed consent form.
  2. Patients with a confirmed diagnosis of EBV-associated hematological malignancies who either: have failed standard treatment; or have voluntarily chosen KSD-101 as prophylactic / anti-relapse therapy by the patient and/or their legal guardian.
• The participant and/or their legal guardian voluntarily agrees to participate and has signed the informed consent form.

Exclusion Criteria:

• Female patients who are pregnant (positive urine or serum pregnancy test), breastfeeding, or male/female patients planning to conceive within 1 year after enrollment.
• Patients positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the upper limit of normal; patients positive for anti-HCV antibody and peripheral blood HCV RNA; patients positive for anti-HIV antibody; or patients positive for syphilis-specific antibody.
• Patients with central nervous system (CNS) involvement (e.g., cerebral edema requiring steroid intervention, or progressive brain metastasis).
• Patients with uncontrolled infectious disease within 4 weeks prior to screening.
• Patients with severe underlying diseases, including cardiovascular disease, respiratory disease, renal insufficiency, coagulation disorders, autoimmune disease, or immunodeficiency disease.
• Patients who have received prophylactic live or attenuated live vaccines within 4 weeks prior to screening.
• Patients who have participated in other clinical studies within 4 weeks prior to screening.
• Patients with a history of severe drug allergy or penicillin allergy.
• Patients with a history of drug abuse or addiction.
• Any other conditions deemed inappropriate for study enrollment by the investigator team.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
KSD-101 therapy	Biological: Autologous dendritic cell vaccine; Subcutaneous injection, once every 2 weeks for 3-5 doses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	The proportion of patients with complete and partial response after treatment.	Baseline up to 24 months after DC vaccines injection.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response Rate	The proportion of patients with complete response after treatment.	Baseline up to 24 months after DC vaccines injection.
Disease Control Rate	The proportion of patients with complete response, partial response, and stable disease after treatment.	Baseline up to 24 months after DC vaccines injection.
Duration of Response	Duration of response is defined as the period from the first response (at least PR) to first occurrence of disease progression or relapse, or death from any cause, whichever occurred first.	From enrollment to study completion (up to approximately 24 months)
Progression-free survival	Progression-free survival is defined as the time from enrollment to the first occurrence of disease progression or relapse, or death from any cause, whichever occurred first.	Baseline up to data cut-off (up to 24 months)
Overall survival rate	Overall survival is defined as the time from enrollment to death from any cause.	Baseline up to data cut-off (up to 24 months)
Treatment-Related Adverse Events rate as assessed by CTCAE version 5.0	Adverse events will be graded by the investigator according to the NCI-CTCAE Version 5.0.	From enrollment to study completion (up to 24 months)
Changes of EBV DNA load, lymphocytes and cytokines		From enrollment to study completion (up to 24 months)

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: KSD-101-RW102